St. Jude Medical is giddy with excitement about the results of four studies presented at Heart Rhythm Society’s 29th Annual Scientific Sessions in San Francisco this week. The multicenter studies have shown that the company’s Riata ST Optim leads, designed for implantable cardioverter defibrillators (ICD) or cardiac resynchronization therapy (CRT-D) devices, perform extremely well in clinical settings. The company describes these leads as “highly advanced tachycardia pacing leads, with an overlay of St. Jude Medical’s innovative Optim insulation and a design intended to ease implant, and promote reliability.”
The studies analyzed the experience of 7,498 patients who were implanted with Riata leads as part of their implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) systems. All sites participating in the four studies (ACT, OPTIMUM, RHYTHM and PAS; see below for a description of the studies) were monitored. To ensure the data were as accurate as possible, each patient’s source records were individually reviewed to be certain that all lead-related complications (further sub-categorized as fracture, insulation damage, perforation or dislodgment) were reported.
The data showed that adverse event rates for all categories of lead-related complications were very low. Overall, the Riata leads’ fracture rates were 0.09 percent (9 in 10,000), insulation damage rates were 0.13 percent (13 in 10,000, with no insulation failures exhibited in Riata leads utilizing Optim(R) insulation), perforation rates were 0.31 percent (31 in 10,000), and dislodgement rates were 0.88 percent (88 in 10,000). These adverse events rates are significantly lower than many previously reported rates in the medical literature on ICD leads.
The results are believed to be the largest and broadest analysis of lead-related complications ever to be presented, especially with complete data monitoring, and unlike reports of single-center experiences or case reports, should best represent real-world experience in a wide range of implanter’s hands.
The results from these studies are particularly significant given the duration of follow-up, which was a median of 22 months for the four studies.
Press release: Results from Studies Evaluating High-Voltage Lead Performance Presented at Heart Rhythm Society’s 29th Annual Scientific Sessions …
Product page: Riata® ST OptimTM Defibrillation Lead …
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